CTRI/2024/11/077464尚未招募不适用
Comparative Evaluation of Efficacy of Demineralized Freeze Dried Bone Allograft (DFDBA)With or Without Recombinant Human Bone Morphogenetic Protein (Rh-BMP2) in the Treatment of Human Intrabony Periodontal Defects. A Clinico-Radiographic Study
Ginni Verma1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical attachment level/ Relative attachment level, Radiographic bone fill
研究概览
简要总结
Patients with intrabony defects confirmed with a radiograph, will be subjected to open flap debridement + DFDBA with or without rhBMP-2. Patient will be inducted for study and after obtaining written consent. Phase 1 therapy will be carried out. This will be followed by the surgical procedure in the patients as mentioned above. Patient will be recalled after 1 week for re-evaluation and assessment followed by 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group ranging from 20-55 years.
- •Patients having minimum 20 teeth.
- •Clinical attachment loss ≥ 3mm 4) Subjects of either sex having Generalised Chronic Periodontitis 5) Subjects who are systemically healthy with no contraindication to Periodontal surgery.
- •Presence of PD ≥ 5mm with radiographic evidence of angular bone loss.
- •Compliant subjects.
排除标准
- •Subjects having any deleterious habits, such as smoking or tobacco chewing.
- •Subjects with history of any systemic disease.
- •Subjects who are sensitive to or shows any allergic reaction to any medication or any ingredient of the test- material.
- •Periodontal defect sites with one walled intra-bony defect.
- •Subjects showing unacceptable oral hygiene compliance during / after Phase-I therapy.
- •Pregnant or lactating females.
- •Subjects having undergone any periodontal therapy in the past three months.
- •Patient with any bleeding disorders.
- •Patient taking any medication which may affect wound healing.
- •Non-compliant subjects.
结局指标
主要结局
Clinical attachment level/ Relative attachment level, Radiographic bone fill
时间窗: 3 Months and 6 Months
次要结局
- Probing pocket depth(3 Months and 6 Months)
研究者
Ginni Verma
Subharti Dental College and Hospital
研究点 (1)
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